[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biliary-strictures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biliary-strictures":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100585645","phase-2-pharmacologic-approaches-to-preventing-primary-sclerosing-cholangitis-recurrence-after-liver-transplantation-100585645",false,"NCT06905054","Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation","Peroxisome Proliferator-Activated Receptor Agonists to Prevent Primary Sclerosing Cholangitis Recurrence After Liver Transplantation","Inclusion criteria:\n\n* Adults aged 18-75 irrespective of gender who have undergone LT for PSC or PSC-related liver malignancy between 1 year and 7 years (inclusive) prior to study enrollment\n* Absence of rPSC at time of study enrollment\n* At least one of the following additional features that increase risk of rPSC\n\n  * LT performed for cholangiocarcinoma\n  * Concurrent inflammatory bowel disease\n  * Any episode of cytomegalovirus viremia in the post-transplant period before study enrollment\n  * Any episode of acute cellular rejection in the post-transplant period before the study enrollment\n* If target enrollment of 40 patients is not achieved during the first 6 months of study, we will remove f(iii) inclusion criteria to expand enrollment to any patient meeting the other inclusion\u002Fexclusion criteria.\n* Due to lab requirements, we will only enrol patients who are within a 3 hour driving distance of Mayo Clinic Arizona and\u002For are willing to travel to Mayo Clinic Arizona at 4 month intervals during the study at own cost.\n\nExclusion criteria:\n\n* Presence of ischemic cholangiopathy which can mimic rPSC\n* LT performed for primary biliary cholangitis or autoimmune hepatitis, or PSC with overlapping primary biliary cholangitis or autoimmune hepatitis, which may recur after LT and confound assessment of cholestasis\n* Unaddressed post-LT hepatic artery compromise (e.g thrombosis, stenosis) which can mimic rPSC\n* History of total colectomy for curative treatment of ulcerative colitis which reduces risk of rPSC\n* Baseline GFR \\\u003C30 ml\u002Fmin which precludes administration of fenofibrate\n* Previously known intolerance or allergy to fenofibrate\n* Other clinically significant comorbid condition, including inability to provide consent and psychiatric conditions, which in the opinion of the study team, may interfere with patient treatment, safety, assessment, or compliance with the treatment\n* Female participants that are pregnant or planning to become pregnant","ALL","18 Years","75 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study aims to determine the efficacy of 36 months once-daily fenofibrate in preventing clinically-detectable recurrence of primary sclerosing cholangitis after liver transplantation, compared with a historical control cohort that was not treated with",[27,28,29,30],"Primary Sclerosing Cholangitis","Liver Transplant, Complications","PSC","Biliary Strictures",[32,33,34,35,36,37,38],"primary sclerosing cholangitis","recurrent primary sclerosing cholangitis","liver transplant complication","fenofibrate","fibrate","PPAR agonist","peroxisome proliferated activated receptor agonist","RECRUITING","2025-06-25",{"date":42,"type":43},"2025-06-27","ACTUAL",{"date":45,"type":43},"2025-04-15",{"date":47,"type":21},"2028-07-01",{"name":49,"class":50},"Mayo Clinic","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":5},"100563306","endoscopic-ultrasound-guided-fine-needle-biopsy-for-tissue-sampling-of-biliary-strictures-a-multicenter-prospective-study-100563306","NCT06614452","Endoscopic Ultrasound-guided Fine-needle Biopsy for Tissue Sampling of Biliary Strictures: a Multicenter Prospective Study","Inclusion Criteria:\n\n* Age ≥18 years\n\n  * Suspicious biliary stricture in absence of an abdominal mass at cross-sectional imaging\n  * Distal and peri-hilar biliary strictures\n  * Informed consent provided by the patient or the closest relative\n\nExclusion Criteria:\n\n* Presence of a pancreatic or abdominal mass structuring the common bile duct\n\n  * EUS not feasible\n  * Known bleeding disorder that cannot be sufficiently corrected with fresh frozen plasma (FFP)\n  * Use of anticoagulants that cannot be discontinued\n  * INR \\>1.5 or platelet count \\<50.000\n  * Pregnancy",{"count":59,"type":21},45,[61],"NA","After the disappointing results of first-generation reverse bevel fine-needle biopsy (FNB) needles, newer 'third generation' endoscopic ultrasound (EUS) needles were developed, known as the \"end-cutting\" needles. These needle types have shown excellent diagnostic accuracy (\\>90%) in pancreatic masses and several other lesions, even without rapid on site evaluation (ROSE) and are not associated with increased adverse event incidence . The main design of end-cutting FNB needles are the Franseen type, which has three symmetrically distributed needle points and cutting edges, and the Fork-tip type which has 2 protruding asymmetrical sharp points and six distal cutting edges; however, other end-cutting needles are currently available such as the three-prong asymmetric tip needle and the Menghini tip needle.\n\nGiven the significant increase in diagnostic accuracy and sensitivity observed in other abdominal lesions, these needles are expected to improve the diagnostic outcomes of EUS-FNB of \"pure\" biliary strictures although clinical data are still lacking.\n\nThe aim of this study is to ascertain the impact of end-cutting FNB needles in the diagnostic algorithm of biliary strictures in absence of a clear pancreatic or abdominal mass.\n\nThis is a multicenter international observational prospective study. Consecutive patients diagnosed with biliary strictures in absence of a pancreatic or abdominal mass will be assessed for eligibility.\n\nPatients with jaundice requiring decompression, will undergo endoscopic retrograde cholangiopancreatography (ERCP) with tissue sampling (brushing and\u002For biopsy) and biliary drainage, preferably in the same session immediately after EUS-FNB.\n\nEndoscopic ultrasound will be performed using a curvilinear array echoendoscope. FNB with 22G or 25G end-cutting needles will be performed. The size of the needles will be based on the personal choice of the endoscopist. Likewise, the sampling technique, whether using the \"slow-pull\", the \"dry suction\", or the \"wet suction\", will be based on the physician's choice. Three passes will be performed as per current guidelines. Specimens will be collected in 3 vials to allow for analysis according to needle pass; one for the first pass, one for the second pass, and one for the third and any eventual subsequent passes.\n\nThe ROSE will not be available in this study. Primary outcome will be diagnostic sensitivity of EUS-FNB and 45 patients will be prospectically enrolled.",[30],[65,66,67],"biliary strictures","EUS-FNB","Cancer","2024-09-25",{"date":70,"type":43},"2024-09-26",{"date":72,"type":43},"2024-09-10",{"date":74,"type":21},"2025-10-20",{"name":76,"class":50},"Ospedali Riuniti di Foggia"]